510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974002Substantially Equivalent

Ethanol-Sl Assay, Catalogue Number 240-12

Sekisui Diagnostics P.E.I. Inc., Charlottetown, P.E.I., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974002 is the FDA 510(k) clearance record for ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12, a class II device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K974002.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Regulation
21 CFR 862.3040
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Chemicals , Ltd. West Royalty Industrial Park,, Charlottetown, P.E.I., CA
510(k) summary
Statement
Third party review
No

Clearances, product code DIC

Trailing 12 months

FDA records hold no clearances under product code DIC in the trailing twelve months.

FDA records show no clearances under product code DIC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260